THE LACK OF BIOLOGICAL RELEVANCE OF THE OFFICIAL IN VITRO DISSOLUTION METHODOLOGY FOR THE IMMEDIATE RELEASE SOLID ORAL DOSAGE FORMS OF KETOCONAZOLE

被引：0

作者：

Adriana, Mitu Mirela ^{[2
]}

Stefan, Radulescu Flavian ^{[1
]}

Mircea, Hirjau ^{[2
]}

Dumitru, Lupuleasa ^{[2
]}

Ionbogdan, Dumitrescu ^{[3
]}

Simona, Miron Dalia ^{[3
]}

机构：

[1] Univ Med & Pharm Carol Davila Bucharest, Fac Pharm, Dept Drug Ind & Pharmaceut Biotechnol, Bucharest 020956, Romania

[2] Univ Med & Pharm Carol Davila Bucharest, Fac Pharm, Dept Pharmaceut Technol & Biopharmaceut, Bucharest 020956, Romania

[3] Univ Med & Pharm Carol Davila Bucharest, Fac Pharm, Dept Pharmaceut Phys & Informat, Bucharest 020956, Romania

来源：

FARMACIA | 2011年 / 59卷 / 06期

关键词：

ketoconazole; tablets; dissolution test; media change; VIVO PERFORMANCE; MEDIA;

D O I：

暂无

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The paper presents the effect of drastic pH variations during in vitro drug release tests on the dissolution profiles of ketoconazole reference immediate release oral solid dosage form. The acidic media induced a rapid and almost complete dissolution of ketoconazole, while the pH change determined an accelerated and continuous precipitation process, almost not dependent on the stirring rate. The results indicate that for generic drug products containing lipophilic weak bases, a rapid dissolution compared to the reference product could explain the reduced biopharmaceutical performances.

引用

页码：853 / 859

页数：7

共 6 条

[1]

[Anonymous], 2006, US PHARM 30 NATL FOR, V30, P25

[2] Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs [J].